Simons F E, Villa J R, Lee B W, Teper A M, Lyttle B, Aristizabal G, Laessig W, Schuster A, Perez-Frias J, Sekerel B E, Menten J, Leff J A
Department of Pediatrics & Child Health, University of Manitoba, Winnipeg, Manitoba, Canada.
J Pediatr. 2001 May;138(5):694-8. doi: 10.1067/mpd.2001.112899.
We tested the hypothesis that adding montelukast to budesonide would improve asthma control in children with inhaled glucocorticoid-dependent persistent asthma.
In a multicenter, randomized, double-blind, crossover study, we compared the benefit of adding montelukast, 5 mg, or placebo once daily to budesonide, 200 microg, twice daily.
After a 1-month run-in with budesonide, 200 microg, twice daily, 279 children were randomized to montelukast or placebo. The mean +/- SD age was 10.4 +/- 2.2 years, the mean forced expiratory volume in 1 second (FEV(1)) was 77.7% +/- 10.6% predicted, and reversibility was 18.1% +/- 12.9%. Compared with adding placebo to budesonide, adding montelukast produced significant improvements in mean percent change from baseline FEV(1) (P =.062 [P =.010 for per-protocol analysis]), mean absolute change from baseline FEV(1) (P =.040), mean increase from baseline in morning (P =.023) and evening (P =.012) peak expiratory flows, decrease in exacerbation days by approximately 23% (P <.001), decreased beta2-agonist use (P =.013), and reduced blood eosinophil counts (P <.001). The treatments did not differ significantly with regard to safety.
Montelukast, 5 mg, added to budesonide improved asthma control significantly, indicated by a small additive effect on lung function and a clinically relevant decrease in asthma exacerbation days.
我们检验了以下假设,即对于吸入糖皮质激素依赖型持续性哮喘患儿,在布地奈德基础上加用孟鲁司特可改善哮喘控制情况。
在一项多中心、随机、双盲、交叉研究中,我们比较了每日一次加用5毫克孟鲁司特或安慰剂与每日两次加用200微克布地奈德的疗效。
在每日两次使用200微克布地奈德进行1个月导入期治疗后,279名儿童被随机分为孟鲁司特组或安慰剂组。平均年龄±标准差为10.4±2.2岁,1秒用力呼气容积(FEV₁)平均为预测值的77.7%±10.6%,可逆性为18.1%±12.9%。与在布地奈德基础上加用安慰剂相比,加用孟鲁司特使FEV₁自基线的平均变化百分比有显著改善(P = 0.062 [按方案分析P = 0.010]),FEV₁自基线的平均绝对变化(P = 0.040),早晨(P = 0.023)和晚上(P = 0.012)呼气峰流速自基线的平均增加,加重天数减少约23%(P < 0.001),β₂受体激动剂使用减少(P = 0.013),以及血液嗜酸性粒细胞计数降低(P < 0.001)。两种治疗在安全性方面无显著差异。
在布地奈德基础上加用5毫克孟鲁司特可显著改善哮喘控制,表现为对肺功能有小的附加作用以及哮喘加重天数有临床相关减少。